Overview In this role you translate statistical objectives into executable programming plans and deliverables across all clinical development phases. You will lead and support programming activities, collaborate with cross-functional teams and CRO partners, and contribute to regulatory submissions. You'll build standards, automation, and QC processes to ensure high-quality results. This position offers impact through shaping analyses, submission-ready outputs, and scalable programming strategies within Madrigal's MASH program.
Compensation / Benefits- equity
- flexible paid time off
- medical, dental, vision and life/disability insurance
- 401(k) with traditional, Roth, and employer match
- mental health benefits via EAP
- voluntary benefits
Responsibilities- Lead and contribute to programming activities across multiple studies and programs
- Develop, validate, review, and maintain SAS programs for data handling, analysis, and reporting
- Review CRO deliverables (SDTM, ADaM, tables, figures, Define.xml) for quality and compliance
- Collaborate with Biostatistics, Clinical Data Management, Regulatory Operations, Medical Writing, and Clinical teams
- Support regulatory submissions (NDA/BLA, ISS/ISE) and pooled analyses
- Develop and maintain programming standards, macros, automation tools, QC procedures, SOPs, and submission processes
- Participate in process improvement and automation initiatives, including AI-enabled solutions
- Coordinate with CRO partners to meet timelines and regulatory requirements
Key requirements- 10+ years in pharmaceutical/biotech with prior regulatory submission experience
- Strong SAS programming experience including SAS Macro development; knowledge of R is a plus
- Understanding of ICH/GCP guidelines
- Deep CDISC SDTM and ADaM experience in clinical trials
- Experience overseeing CRO programming activities
- Experience supporting NDA/BLA submissions and submission validation processes
- Strong communication, organizational, problem-solving, and cross-functional collaboration skills
- strong communication
- organizational skills
- problem-solving
- SAS programming with macro development
- CDISC SDTM and ADaM modeling
- regulatory submission support (NDA/BLA, Define.xml, ISS/ISE)
